Regulatory Affairs Manager
A worldwide biotechnology company situated in Berkshire and operating in over 70 markets worldwide is looking for a Regulatory Affairs Manager. The company specialises in neurological conditions and puts a great emphasis on teamwork and delivering biological products.
- Developing and implementing innovative global regulatory strategies for product development and approval.
- Defining strategies for meeting and keeping post-approval compliance.
- Responsible for regulatory documents, submissions and compliance issues.
- Representing the company with contractors and corporate partners.
- Providing regulatory support for various departments, projects and teams/committees.
- Successfully developing and implementing regulatory strategies for new registration submissions including post-approval compliance for assigned portfolio in the region.
- Providing strategic guidance and regulatory leadership at project team meetings as well as represent the Global Emerging Markets strategy for assigned products in the region.
- Identifying and assessing regulatory risks associated with the execution of regulatory strategies in assigned region.
- Defining strategies to mitigate risks and keeping abreast of changes in regional legislation.
- Coordinating the preparation of the regulatory submissions including responses to questions from the Health Authorities.
- Leading preparation and representing the company at Health Authority meetings.
- Highlighting key issues that may impact the execution of regulatory strategy across territories.
- Preparing and delivering effective presentations for external and internal audience - Demonstrate strong organisational skills, including the ability to prioritize personal and any direct reports workload.
Skills and Requirements:
- Minimum of 6 to 8 years of pharmaceutical/biotechnology industry experience (including 5 years + of Regulatory Affairs experience).
- BA or BS University degree required. Life/Health Sciences preferred.
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, drug safety, scientific and manufacturing staff.
- Building and maintaining effective relationships with both internal as well as external stakeholders.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion and influence.
- Good organisational skills, including efficiency, punctuality and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Emily Oakley-Keenan at 0207 440 0633 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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